Boceprevir in End Stage Renal Disease (ESRD)

• Status: Withdrawn
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety and efficacy of triple therapy with pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha; Interferons; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

1. Adult (ages 18-75)

2. Hepatitis C Virus ribonucleic acid (HCV RNA) 1000 IU/mL or greater

3. Hepatitis C Virus (HCV) genotype 1

4. End stage renal disease on hemodialysis

5. Females of child bearing potential must be using an adequate method of contraception throughout the study and must have a negative pregnancy test prior to the start of treatment.

Exclusion Criteria:

1. Intolerance to peg-IFN or ribavirin with prior treatment course.

2. Prior treatment with protease inhibitor (telaprevir or boceprevir) or experimental protease inhibitor

3. Significant cytopenias:

1. Absolute neutrophil count (ANC) < 1000/mm3, OR

2. Hemoglobin (Hgb) <10.5 g/dL, or

3. Platelet count < 50,000/mm3

4. Significant laboratory abnormalities

1. Direct bilirubin > 1.5 x upper limit of normal (ULN)

2. Total bilirubin > 1.6 mg/dL unless due to Gilbert's disease

3. Prothrombin time (PT)/Partial thromboplastin time (PTT) > 10% above laboratory reference range

4. Thyroid Stimulating Hormone (TSH) > 1.2 x ULN or < 0.8 x lower limit of normal (LLN)

5. Uncontrolled depression or psychiatric disease

6. Uncontrolled cardiopulmonary or cardiovascular disease

7. Autoimmune diseases except for treated thyroid disease

8. Active substance abuse within 6 months of initiation of treatment

9. Recent (within 4 weeks) episode of infection requiring systemic antibiotics

10. Any medical condition that would be predicted to be exacerbated by therapy or that would limit study participation

11. Any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study

12. Human immunodeficiency virus (HIV) or Hepatitis B Virus (HBV) co-infection

13. Hepatocellular carcinoma (HCC) (Patients with HCC who are listed for liver transplantation may be included.)

14. Other significant chronic liver disease diagnosis

15. Evidence of decompensated liver disease

16. Solid organ transplant recipient (Patients who have a history of renal transplant, and have experienced kidney graft loss, and are not on immunosuppression may be included.)